Exxua: which tox species, and why?

“Repeated-dose toxicology studies of adequate duration and at MTDs were performed in rats and dogs.”

“In humans, 2 major metabolites of gepirone have been identified: 1-PP (which is also a metabolite of buspirone, currently approved and marketed as an anxiolytic) and 3’-OH-gepirone. Both of these metabolites have been identified and found to be present in substantial amounts (many times the levels of gepirone) in plasma of the 2 major species used in the preclinical studies, namely rats and dogs, following gepirone administration.”

“In the 1-year study in dogs (4, 8, and 16 mg/kg/day orally, in a capsule), decreases in body weights (and food consumption at the HD) limited doses.”